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Treatment of Patients With Transitional-Cell Carcinoma of the Urothelial Tract With Gemcitabine, Docetaxel and Filgrastim
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with gemcitabine and docetaxel plus filgrastim in treating patients who have locally recurrent or advanced urothelium cancer.
OBJECTIVES: I. Determine the efficacy of gemcitabine, docetaxel, and filgrastim (G-CSF) in patients with locally recurrent or advanced transitional cell carcinoma of the urothelial tract. II. Determine the toxicity of this regimen in these patients. III. Determine the disease-free and overall survival of this patient population treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no). Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 9 and continuing until blood counts recover. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who respond to treatment may undergo surgery and 6-8 weeks later receive 2 more courses of chemotherapy. Patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 23-40 patients who have not received prior chemotherapy and 23 patients who have received prior chemotherapy will be accrued for this study within 2 years.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of California San Diego
La Jolla, California, United States
Sacramento Center for Hematology and Medical Oncology
Sacramento, California, United States
Washington Cancer Institute
Washington D.C., District of Columbia, United States
Center for Hematology-Oncology
Boca Raton, Florida, United States
Oncology-Hematology Associates of North Illinois, Ltd.
Gurnee, Illinois, United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States
St. Joseph Medical Center
Towson, Maryland, United States
Hematology & Oncology Associates of Southern Michigan
Jackson, Michigan, United States
Hematology Oncology Associates of Central New York
Syracuse, New York, United States
Memphis Cancer Center, Inc.
Memphis, Tennessee, United States
Start Date
October 1, 1999
Last Updated
December 4, 2013
filgrastim
BIOLOGICAL
docetaxel
DRUG
gemcitabine hydrochloride
DRUG
Lead Sponsor
Amgen
NCT04235764
NCT00026884
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03375307